Lenalidomide is very similar to thalidomide, a drug which has caused severe (possibly fatal) birth defects when used during pregnancy. If lenalidomide is taken during pregnancy, it may also cause severe (possibly fatal) birth defects. Women who are pregnant or who may become pregnant must not use lenalidomide. Women must have two negative pregnancy tests before starting lenalidomide (the first test 10 to 14 days before the first dose and the second test within 24 hours before the first dose). Women must also continue to have pregnancy tests regularly during treatment (every 2 to 4 weeks).

Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 4 weeks before starting lenalidomide, during use, and for 4 weeks after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late or if you have irregular bleeding, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor right away.

Because lenalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Continue using condoms and other birth control as directed until 4 weeks after lenalidomide treatment has been stopped.

You should have a blood test for hepatitis B virus before starting treatment. Some people with this virus may have a serious flare-up when using lenalidomide.

To receive this medication, all doctors, pharmacists, and patients must understand, agree to, and carefully follow the requirements of the Revlimid REMS Program created by the U.S. Food and Drug Administration. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

This medication may cause a low number of white blood cells and platelets. Your doctor will monitor you closely while you take this medication and may adjust the dose of the medication or stop the medication based on your lab test results. Get medical help right away if you develop any of the following symptoms: signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough), easy bleeding/bruising.

Lenalidomide may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you smoke, or have a history of blood clots, high blood pressure, or high cholesterol, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. To lower your risk, your doctor may prescribe an additional medication. Before using lenalidomide, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if you have any signs of a blood clot, including: shortness of breath, chest/jaw/left arm pain, unusual sweating, confusion, pain/swelling/redness in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.

Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions.

Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.

Read the Medication Guide provided by your pharmacist before you start taking lenalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with water. For treatment of certain conditions, you may be instructed to take this medication in cycles (once daily for 21 days, then stopping the medication for 7 days). The dosage is based on your medical condition, response to treatment, and lab test results. Be sure to follow your doctor's directions carefully.

Do not open, chew, or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.

Use this medication regularly to get the most benefit from it. Remember to take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Diarrhea, stomach/abdominal pain, nausea/vomiting, loss of appetite, constipation, dizziness, dry skin, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

Some people treated with this medication may rarely get other cancers. Consult your doctor for more details.

Lenalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

low back/side pain (flank pain)

signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)

muscle spasms/weakness

People taking lenalidomide may have worsening of their symptoms (tumor flare reaction). If you have tender/swollen lymph nodes, fever, pain, or rash, contact your doctor right away.

This drug helps many people live longer. However, some people who have used lenalidomide have died sooner than expected, especially if they had high white blood cell or tumor cell counts. Talk with your doctor about the risks and benefits of using this medication.

Lenalidomide may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as:

nausea/vomiting that doesn't stop

loss of appetite

severe stomach/abdominal pain

yellowing eyes/skin

dark urine

Lenalidomide can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

rash

itching/swelling (especially of the face/tongue/throat)

severe dizziness

trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Lenalidomide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Do not donate blood or sperm while using lenalidomide and for 4 weeks after stopping this drug.

Older adults may be more sensitive to the side effects of this drug.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.

Lenalidomide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, stop taking lenalidomide and tell your doctor right away. If you are male and have had unprotected sex with a woman who is or can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors right away.

It is unknown if lenalidomide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised May 2019.

Copyright(c) 2019 First Databank, Inc.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.